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One-year experience with intravenous treprostinil for pulmonary arterial hypertension.
J Heart Lung Transplant. 2013 Sep; 32(9):889-96.JH

Abstract

BACKGROUND

Intravenous (IV) epoprostenol has been the mainstay of therapy in advanced pulmonary arterial hypertension (PAH). Continuous IV treprostinil has several potential advantages over IV epoprostenol; however, there has been a lack of published long-term efficacy and safety data on IV treprostinil in PAH.

METHODS

We conducted a 48-week, multicenter, prospective, open-label, uncontrolled, study of continuous IV treprostinil in 16 patients on no prior PAH specific therapy at baseline (de novo), or 31 patients transitioned at baseline from IV epoprostenol (transition). The primary end point was change in exercise capacity assessed by the 6-minute walk distance (6MWD) test.

RESULTS

In de novo patients, IV treprostinil increased the mean ± standard error 6MWD by 125 m from 332 ± 21 m at baseline to 457 ± 26 m at Week 48. There were also improvements in the secondary end points of Naughton-Balke treadmill time, Borg Dyspnea Score, and hemodynamics at Week 48 compared with baseline. In 23 patients transitioned from IV epoprostenol with 48-week follow-up data, 6MWD, hemodynamic measures, and World Health Organization functional class at Week 48 were all stable compared with baseline. Side effects were generally mild and consistent with those reported with prostacyclin treatment. During the study, 5 patients died of causes not considered related to the therapy, and 7 discontinued due to adverse events.

CONCLUSIONS

In this open-label trial, continuous IV treprostinil for 1 year appears to be safe and effective in de novo PAH patients and those transitioned from IV epoprostenol.

Authors+Show Affiliations

Division of Cardiovascular Diseases, Allegheny General Hospital, Pittsburgh, Pennsylvania 15212, USA. rbenza@wpahs.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23953817

Citation

Benza, Raymond L., et al. "One-year Experience With Intravenous Treprostinil for Pulmonary Arterial Hypertension." The Journal of Heart and Lung Transplantation : the Official Publication of the International Society for Heart Transplantation, vol. 32, no. 9, 2013, pp. 889-96.
Benza RL, Tapson VF, Gomberg-Maitland M, et al. One-year experience with intravenous treprostinil for pulmonary arterial hypertension. J Heart Lung Transplant. 2013;32(9):889-96.
Benza, R. L., Tapson, V. F., Gomberg-Maitland, M., Poms, A., Barst, R. J., & McLaughlin, V. V. (2013). One-year experience with intravenous treprostinil for pulmonary arterial hypertension. The Journal of Heart and Lung Transplantation : the Official Publication of the International Society for Heart Transplantation, 32(9), 889-96. https://doi.org/10.1016/j.healun.2013.06.008
Benza RL, et al. One-year Experience With Intravenous Treprostinil for Pulmonary Arterial Hypertension. J Heart Lung Transplant. 2013;32(9):889-96. PubMed PMID: 23953817.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - One-year experience with intravenous treprostinil for pulmonary arterial hypertension. AU - Benza,Raymond L, AU - Tapson,Victor F, AU - Gomberg-Maitland,Mardi, AU - Poms,Abigail, AU - Barst,Robyn J, AU - McLaughlin,Vallerie V, PY - 2013/01/06/received PY - 2013/06/12/revised PY - 2013/06/12/accepted PY - 2013/8/20/entrez PY - 2013/8/21/pubmed PY - 2014/4/4/medline KW - prostacyclin KW - pulmonary arterial hypertension KW - treprostinil SP - 889 EP - 96 JF - The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation JO - J. Heart Lung Transplant. VL - 32 IS - 9 N2 - BACKGROUND: Intravenous (IV) epoprostenol has been the mainstay of therapy in advanced pulmonary arterial hypertension (PAH). Continuous IV treprostinil has several potential advantages over IV epoprostenol; however, there has been a lack of published long-term efficacy and safety data on IV treprostinil in PAH. METHODS: We conducted a 48-week, multicenter, prospective, open-label, uncontrolled, study of continuous IV treprostinil in 16 patients on no prior PAH specific therapy at baseline (de novo), or 31 patients transitioned at baseline from IV epoprostenol (transition). The primary end point was change in exercise capacity assessed by the 6-minute walk distance (6MWD) test. RESULTS: In de novo patients, IV treprostinil increased the mean ± standard error 6MWD by 125 m from 332 ± 21 m at baseline to 457 ± 26 m at Week 48. There were also improvements in the secondary end points of Naughton-Balke treadmill time, Borg Dyspnea Score, and hemodynamics at Week 48 compared with baseline. In 23 patients transitioned from IV epoprostenol with 48-week follow-up data, 6MWD, hemodynamic measures, and World Health Organization functional class at Week 48 were all stable compared with baseline. Side effects were generally mild and consistent with those reported with prostacyclin treatment. During the study, 5 patients died of causes not considered related to the therapy, and 7 discontinued due to adverse events. CONCLUSIONS: In this open-label trial, continuous IV treprostinil for 1 year appears to be safe and effective in de novo PAH patients and those transitioned from IV epoprostenol. SN - 1557-3117 UR - https://www.unboundmedicine.com/medline/citation/23953817/One_year_experience_with_intravenous_treprostinil_for_pulmonary_arterial_hypertension_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1053-2498(13)01300-4 DB - PRIME DP - Unbound Medicine ER -